PROJECT

A Multi-centric Parallel arm Randomized Clinical trial to improve treatment outcomes among persons with drug sensitive pulmonary TB treated with 4 or 6 months of High dose Rifampicin containing regimens with or without Levofloxacin (PRaCTISe-HR)

Feb 2026 - July 2029

Objectives:

To determine the efficacy of High dose Rifampicin containing regimens with or without Levofloxacin in improving treatment outcomes (increased cure , lower mortality or recurrence rates) in new or retreatment drug sensitive pulmonary TB patients aged > 14 years at 2 years post treatment.

Study Overview:

Multi-centric parallel arm RCT conducted across 15 sites in India among 2500 persons living with drug sensitive TB seeks to address two key research questions: 1) Whether higher-dose rifampicin administered for six months can improve treatment efficacy reflected by reduced recurrence and reduced early mortality compared to the standard of care - Test Regimen 1: 2HR25ZE / 4HR10E - Test Regimen 2: 2HR25ZE / 4HR25E 2) Whether treatment duration can be safely shortened to four months by incorporating levofloxacin - Test Regimen 3: 2HR25ZEL / 2HR25EL (daily for 4 months)

Study Approach:

Expected Public Health Impact:

The trial will furnish evidences on the use of High dose rifampicin in improving treatment outcomes, treatment shortening and recurrence free survival in drug sensitive TB patients.